Prosecution Insights
Last updated: April 19, 2026
Application No. 17/609,137

MONITORING AND ALTERING THE GUT MICROBIOME IN DISEASE

Final Rejection §103
Filed
Nov 05, 2021
Examiner
EDWARDS, JESSICA FAYE
Art Unit
1657
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The General Hospital Corporation
OA Round
4 (Final)
45%
Grant Probability
Moderate
5-6
OA Rounds
2y 6m
To Grant
91%
With Interview

Examiner Intelligence

Grants 45% of resolved cases
45%
Career Allow Rate
19 granted / 42 resolved
-14.8% vs TC avg
Strong +46% interview lift
Without
With
+45.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
38 currently pending
Career history
80
Total Applications
across all art units

Statute-Specific Performance

§101
10.2%
-29.8% vs TC avg
§103
31.9%
-8.1% vs TC avg
§102
14.0%
-26.0% vs TC avg
§112
26.9%
-13.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 42 resolved cases

Office Action

§103
Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . DETAILED ACTION This application is a US national phase of PCT/US20/31694, filed May 6, 2020 with a provisional application 62/844045, filed May 6, 2019. Applicant’s amendment filed January 30, 2026 is acknowledged. Claims 2-4 and 7-17 are canceled, and claim 1 is amended. Currently claims 1, 5-6, and 18 are pending and under examination. The previous claim objection in Non-Final office action mailed October 31, 2025 is withdrawn due to Applicant’s amendment to the claims filed January 30, 2026. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1, 5-6, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Segal et al. (WO 2016/185469 A1, hereinafter “Segal”) in view of Li et al. (US 2019/0209626 A1, cited in PTO-892 mailed 10/31/2025, hereinafter “Li”). Segal teaches methods of improving the glucose response in subjects by providing probiotic compositions or agents which specifically reduce bacterial species (abstract). Segal teaches the probiotic composition comprises at least one Faecalibacterium prausnitzii L2-6 and Bifidobacterium longum sp. longum F8 (pg. 4, lines 22-32, pg. 5, lines 1-6). Segal teaches according to an aspect of some embodiments, providing a probiotic composition comprising at least two bacteria which is categorized as beneficial according to Table 5 (pg. 4, lines 14-17), which lists Bacteroides ovatus as beneficial (pg. 65, col. 2). Segal teaches the probiotic bacteria may be in any suitable form, such as a powdered dry form (i.e. lyophilized) and encapsulated by standard techniques known in the art (pg. 19, lines 24-30). Segal teaches the composition may be in the form of a food product, and comprise a juice, which meets the limitations of claims 5-6, and 18 (pg. 20, lines 4-7). Segal does not explicitly teach the composition includes Bacteroides ovatus CL03T12C18. However, Li teaches probiotic compositions comprising at least one bacterium from Bacteroidetes phylum and at least one bacterium from Firmicutes phylum that confer health benefits to the subject (abstract). Li teaches bacteria from Bacteroidetes can be the strain Bacteroides ovatus CL03T12C18 (pg. 6, Table 3, [0060]) and bacteria from Firmicutes can be the species Faecalibacterium prausnitzii, reciting various strains [0051, 0063]. Li teaches the probiotic composition can be formulated for oral administration, such as tablets or capsules [0066]. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the strains F. prausnitzii L2-6, B. longum subsp. longum F8, and a Bacteroides ovatus strain, as taught by Segal, and the Bacteroides ovatus CL03T12C18 strain taught by Li, to formulate a nutritional probiotic composition to confer health benefits with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to combine various well-known probiotic strains in a composition as disclosed by the prior art to formulate the health beneficial composition as claimed, since these strains are known to inherently possess similar functions and attributes, thus are interchangeable in probiotic pharmaceutical compositions. Response to Arguments Applicant’s arguments with respect to claims 1, 5-6, and 18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657 /JESSICA EDWARDS/ Examiner Art Unit 1657
Read full office action

Prosecution Timeline

Nov 05, 2021
Application Filed
Nov 12, 2024
Non-Final Rejection — §103
Mar 18, 2025
Response Filed
May 15, 2025
Final Rejection — §103
Jul 21, 2025
Response after Non-Final Action
Sep 22, 2025
Request for Continued Examination
Sep 25, 2025
Response after Non-Final Action
Oct 29, 2025
Non-Final Rejection — §103
Jan 30, 2026
Response Filed
Feb 21, 2026
Final Rejection — §103 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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2y 5m to grant Granted Jan 06, 2026
Patent 12509673
NOVEL OF L-THREONINE DEHYDRATASE VARIANT AND METHOD OF PRODUCING L-ISOLEUCINE USING THE SAME
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Patent 12509706
METHODS FOR PREPARING PANTOIC ACID, PANTOTHENIC ACID AND PANTHENOL AS WELL AS SALTS THEREOF
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Patent 12410454
PRODUCTION OF HUMAN MILK OLIGOSACCHARIDES IN MICROBIAL HOSTS WITH ENGINEERED IMPORT / EXPORT
2y 5m to grant Granted Sep 09, 2025
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

5-6
Expected OA Rounds
45%
Grant Probability
91%
With Interview (+45.9%)
2y 6m
Median Time to Grant
High
PTA Risk
Based on 42 resolved cases by this examiner. Grant probability derived from career allow rate.

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